How to Register a Foreign Cosmetic Facility With FDA Under MoCRA

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC

If you make cosmetics outside the U.S. and want to sell them into the American market, FDA facility registration under MoCRA is a prerequisite — and it's actively enforced. This is the step-by-step path, plus the mistakes that most often delay foreign registrants.

Step 1: Confirm you're required to register

MoCRA requires facilities that manufacture or process cosmetic products for U.S. distribution to register with FDA under Section 607(a). Before you start, confirm:

• Your facility manufactures or processes a cosmetic (not solely an OTC drug — many "cosmeceutical" products are actually OTC drugs and follow a different pathway).

• You don't qualify for the small-business exemption — and remember the exemption does not apply to products that contact the eye's mucous membrane, are injected, are for internal use, or alter appearance for more than 24 hours under customary use.

Not sure whether your product is a cosmetic or an OTC drug? That classification drives everything downstream, and it's worth confirming first.

Step 2: Designate a U.S. Agent

Foreign facilities must name a U.S. Agent — a U.S.-based contact for FDA — as part of registration. The agent must be physically in the U.S. and reachable during business hours. (See do I need a U.S. Agent?) Line this up before you file, because you'll need the agent's details in the submission.

Step 3: Obtain or confirm your FEI number

Registration is tied to an FDA Establishment Identifier (FEI). If your facility has been inspected or previously registered with FDA, you may already have one; if not, you'll request it. Getting the FEI right prevents duplicate or mismatched records later.

Step 4: Submit the facility registration (Form 5066)

Cosmetic facility registration is submitted to FDA — electronically through FDA's Cosmetics Direct system — using Form FDA 5066. You'll provide facility details, the U.S. Agent designation, product categories, and contact information. Accuracy here matters: registration data should match your product listings and your label information.

Step 5: List your products (Form 5067)

Registration and listing are related but separate. After registering the facility, the Responsible Person lists each cosmetic product using Form FDA 5067. (Full detail: MoCRA product listing requirements.)

Step 6: Maintain, renew, and update

• Renew facility registration every two years.

• Update product listings annually, and whenever a product changes.

• Keep your U.S. Agent designation current — update the registration if you change agents.

Common mistakes foreign registrants make

• Treating an OTC drug as a cosmetic (or vice versa) — wrong pathway, rejected or non-compliant filing.

• Using a mailbox as a "U.S. Agent" — it must be a real, reachable U.S. presence.

• Mismatched data across registration, listing, and labels — a frequent trigger for FDA follow-up.

• Letting renewals lapse — an expired registration can interrupt market access.

Want this handled end-to-end? Axentra registers foreign cosmetic facilities, secures FEI numbers, files Forms 5066 and 5067, and can serve as your U.S. Agent — all in one engagement. Start your registration.

See the full obligation set on our MoCRA cosmetics compliance page and the official requirements on FDA's MoCRA page.

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Frequently asked questions

How does a foreign company register a cosmetic facility with FDA?

Confirm registration is required, designate a U.S. Agent, obtain or confirm an FEI number, submit facility registration on Form FDA 5066 via FDA's Cosmetics Direct system, then list products on Form FDA 5067 and maintain renewals.

What form is used for cosmetic facility registration?

FDA Form 5066 is used for cosmetic facility registration; FDA Form 5067 is used for cosmetic product listing.

How often must cosmetic facility registration be renewed?

Facility registration must be renewed every two years, and product listings should be updated annually and whenever a product changes.

Do foreign cosmetic facilities need a U.S. Agent to register?

Yes. A U.S. Agent designation is part of facility registration for foreign facilities and must be in place when you file.